Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.

Titers are given as geometric mean titers (GMTs) calculated on all subjects.

Analysis was performed on the ATP cohort for immunogenicity.

Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Analysis was performed on the ATP cohort for immunogenicity.

Titers are given as GMTs calculated on all subjects.

Analysis was performed on the APT cohort for immunogenicity

Analysis was performed on the ATP cohort for immunogenicity.

Titers are given as geometric mean titers (GMTs) calculated on all subjects.

Analysis was performed on the ATP cohort for immunogenicity

CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.

Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.

CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.

Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.

B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.

A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.

Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.

Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.

Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter.

Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter.

Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.

Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.

Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.

An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed.

Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.

Analysis was performed on those subjects reporting pregnancy during the study period.

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.